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

Model Number	301805M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent cardiac ablation procedure with a preface® guiding sheath with multipurpose curve where brim cap detachment occurred.It was reported that the carto 3 system was displaying noise on the distal ecg of the catheter when connected to the piu.The caller stated that the noise was also seen on the recording system.The caller replaced the cable without resolution.The catheter was replaced and the issue was resolved.The procedure was continued.It was also reported that when pulling the catheter out of the preface® guiding sheath with multipurpose curve that the valve cap came off the end of the sheath.The caller replaced the sheath and the issue was resolved.The procedure was continued.There was no report of patient consequence.The hemostatic valve did not break.The sheath was being used on the patient at the time of the event.No air entered the patient¿s body.The hemodynamics was not compromised, only minimal amount of blood leaked (8-10ml).No intervention was required.A guidewire was inserted and promptly exchanged for another sheath.Noise on the ecg is not mdr-reportable.Brim cap detachment is mdr-reportable.
Additional Manufacturer Narrative
On (b)(6) 2020, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 2/16/2021, the product investigation was completed.It was reported that a patient underwent cardiac ablation procedure with a preface® guiding sheath with multipurpose curve where brim cap detachment occurred.It was reported that the carto 3 system was displaying noise on the distal ecg of the catheter when connected to the piu.The caller stated that the noise was also seen on the recording system.The caller replaced the cable without resolution.The catheter was replaced and the issue was resolved.The procedure was continued.It was also reported that when pulling the catheter out of the preface® guiding sheath with multipurpose curve that the valve cap came off the end of the sheath.The caller replaced the sheath and the issue was resolved.The procedure was continued.There was no report of patient consequence.Device evaluation details: a non-sterile pref,guiding sheath: long,mult cannula and vessel dilator were received for analysis inside a plastic bag.Per visual analysis, the brim cap was observed detached from the hub of the unit and was not returned inside the plastic bag.No anomalies or damages were observed on the internal components of the hub.No other anomalies were observed.A review of the manufacturing documentation associated with lot 17946874 was performed and it was found no internal actions were issued for this lot.The complaint reported by the customer as a brim cap detachment was confirmed since the brim cap was observed detached from the hub of the unit, as received.Brim cap was not returned along the unit.Nevertheless, neither damages nor any anomalies were observed on the internal components of the hub.The cause of the detached brim cap observed on the unit could not be conclusively determined during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: PREFACE GUIDING SHEATH WITH MULTIPURPOSE CURVE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11001384
• Report Number: 2029046-2020-01942
• Device Sequence Number: 630107
• Product Code: DYB
• UDI-Device Identifier: 10846835000061
• UDI-Public: 10846835000061
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 301805M
• Device Catalogue Number: 301805M
• Device Lot Number: 17946874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 12/18/2020; 02/16/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 01/04/2021; 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; RECORDING SYSTEM; THERMOCOOL SMARTTOUCH