MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE; INTRODUCER, CATHETER

Model Number	301803MS
Medical Device Problem Codes	Backflow (1064); Material Twisted/Bent (2981); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Air Embolism (1697); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Initial reporter telephone: (b)(6).(b)(4).Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a preface® guiding sheath with multipurpose curve wherein air entered the patient and the patient had electrocardiogram st segment elevation.When mapping inside the cardiac cavity, st increased, and air was found in the right coronary artery and aorta.When the catheter was removed from the patient¿s body and flushed, the air blew out.This occurred after mapping inside the cardiac cavity.The catheter and the preface® guiding sheath with multipurpose curve were removed from the patient¿s body, and when flushed, air was checked and the preface® guiding sheath with multipurpose curve with air was replaced with sl0.Additional information received indicated the physician said that there was no doubt that air entered from the sheath, but it was unknown whether this product was the cause.
Additional Manufacturer Narrative
On 2-aug-2021, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Also on 2-aug-2021, additional information was received indicating the patient was an 81-year-old-male weighting 65 kg.The issue was discovered during use of biosense webster products.The physician indicated the cause of this issue was unknown.No medical intervention was provided.There was no adverse event after the reported complaint.The patient did not require extended hospitalization.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a preface® guiding sheath with multipurpose curve wherein air entered the patient and the patient had electrocardiogram st segment elevation.When mapping inside the cardiac cavity, st increased, and air was found in the right coronary artery and aorta.The preface® guiding sheath with multipurpose curve was removed from the patient¿s body, and when flushed, air was checked and then the preface® guiding sheath with multipurpose curve with air was replaced with an sl0.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Upon return, bwi received three (3) used preface® guiding sheath with multipurpose curve for evaluation; all of the same lot number.Upon additional follow-up with the customer for clarification as to why three (3) devices were returned, they indicated that all three (3) devices were used during the procedure, however, only one of the returned items was the complaint device.They could not tell which sheath was the complaint device; so all were returned.They indicated only one of the returned devices experienced the air backflow problem, the other two (2) had no problems.As such, all devices were sent to the manufacturer for further investigation.Evaluation results for device a: visual analysis of the returned sample revealed two kink was observed on the body/shaft of the cannula sheath.No anomalies could be observed neither on the hub nor on the cap or on the tip of the received cannula sheath.Functional analysis and dimensional analysis were performed and it was found within specification.The complaint reported by the customer was not confirmed since air didn't flow back into the side port when performing flushing test on the device.Nevertheless, two kinks were observed on the body/shaft of the cannula.Dimensional tests on cannula near the kinks were carried out and results were observed within specification.However, the cause of the reported complaint and the kinks observed on the unit could not be conclusively determined during the analysis; procedural factors and /or handling processes may contribute to this issue.Evaluation results for device b: visual analysis of the returned sample revealed one kink observed on the body/shaft of the cannula sheath.Also no anomalies could be observed neither on the hub nor on the cap or on the tip of the received cannula sheath.Functional analysis and dimensional analysis were performed and it was found within specification.The complaint reported by the customer was not confirmed since air didn't flow back into the side port when performing flushing test on the device.Nevertheless, one kink was observed on the body/shaft of the cannula.Dimensional tests on cannula near the kink was carried out and results were observed within specification.However, the cause of the reported complaint and the kink observed on the unit could not be conclusively determined during the analysis; procedural factors and /or handling process may contribute to this issue.Evaluation results for device c: visual analysis of the returned sample revealed two kink observed on the body/shaft of the cannula sheath.Also, no anomalies could be observed neither on the hub nor on the cap or on the tip of the received cannula sheath.Functional analysis and dimensional analysis were performed and it was found within specification.The complaint reported by the customer was not confirmed since air didn't flow back into the side port when performing flushing test on the device.Nevertheless, two kinks were observed on the body/shaft of the cannula.Dimensional tests on cannula near the kinks were carried out and results were observed within specification.However, the cause of the reported complaint and the kinks observed on the unit could not be conclusively determined during the analysis; procedural factors and /or handling process may contribute to this issue.The identified kinks are not considered to be mdr reportable malfunctions since the device integrity maintained and no internal components exposed to patient.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.A manufacturing record evaluation was performed for the finished devices with lot # 17971280, and no internal action related to the complaint was found during the review.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the product evaluations.As part of quality process all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the adverse events.Investigation findings: mechanical problems identified (c07) / investigation conclusions: cause not established (d15) / component code: tube (g04134) were selected as related to the kinks in the shaft of the devices found during product analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12215813
• Report Number: 2029046-2021-01175
• Device Sequence Number: 3779343
• Product Code: DYB
• UDI-Device Identifier: 10846835000030
• UDI-Public: 10846835000030
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 301803MS
• Device Catalogue Number: 301803MS
• Device Lot Number: 17971280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 08/02/2021; 12/09/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 08/18/2021; 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL0 SHEATH; UNKNOWN CATHETER; UNK_SMARTABLATE PUMP; SL0 SHEATH; UNKNOWN CATHETER; UNK_SMARTABLATE PUMP
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 65 KG