MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CRISTA CATH¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number D7A20131RT

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 Description

It was reported that an unknown patient underwent an unknown ablation procedure with a crista cath¿ electrophysiology catheter.The sterile packaging looked partially unsealed which compromised the protection of the catheter.The sterile packaging looked partially unsealed which compromised the protection of the catheter.There were no patient consequences.Open pouch seal is mdr-reportable.

Manufacturer Narrative

On 1-dec-2022, the product investigation was completed.It was reported that an unknown patient underwent an unknown ablation procedure with a crista cath¿ electrophysiology catheter.The sterile packaging looked partially unsealed which compromised the protection of the catheter.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the ismus catheter.A manufacturing record evaluation was performed for the finished device 30305132m number, and no internal action was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 3-nov-2022, 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).

• Brand Name: CRISTA CATH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15656949
• MDR Text Key: 302845227
• Report Number: 2029046-2022-02619
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835005042
• UDI-Public: 10846835005042
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K953768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2022
• Device Model Number: D7A20131RT
• Device Catalogue Number: D7A20131RT
• Device Lot Number: 30305132M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 10/24/2022
• Supplement Dates Manufacturer Received: 11/03/2022; 12/01/2022
• Supplement Dates FDA Received: 11/20/2022; 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1