MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D128211

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

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

Event Date 09/02/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection of the returned device was performed in accordance with bwi procedures.Visual inspection was performed, and one spline was found stretched and bent, the spline electrodes were observed out of their place.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device (b)(4), and no internal action was found during the review.The issue reported by the customer was confirmed, however, no conditions were found on the device that might contributed to damage observed, this could be related to the interaction the device with the sheath, however, this cannot be conclusively determined.The instructions for use contain (ifu) the following recommendations: do not introduce the catheter into a guiding sheath with the catheter¿s distal spines folded backward toward the handle.Do not use excessive force to advance or withdraw the catheter through the guiding sheath when resistance is encountered.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Initial reporter phone: (b)(6).Explanation of codes: component code: (b)(4).Component code: (b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter for which biosense webster¿s product analysis lab (pal) identified an electrode damage.It was initially reported by the customer that when pushing into sl0 sheath and trying to pull it out from the sheath, one of the spines protrudes into the sl0 side pole and cannot be pulled back.There was resistance and when pulling it out of the patient¿s body, the doctor pulled pentaray nav catheter out too strongly and the spine coating was damaged, torn.The pentaray nav high-density mapping eco catheter was exchange and the procedure was continued and completed without any problem.There was no patient consequence.The customer¿s reported issue of damaged tip and resistance with the sheath are not considered to be mdr reportable since the potential that these could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 30-nov-2022, the bwi pal revealed that a visual inspection of the returned device spline e was stretched and bent, the electrodes on spline e were bent, with rough edges, without pu on the edges and were moved out place.These findings were reviewed and determined to be mdr reportable malfunction for the rough edges of the electrode.

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 16030826
• MDR Text Key: 308473349
• Report Number: 2029046-2022-03225
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2022

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 Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30779527L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2022
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2022
• 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
• Treatment: PENTARAY NAV ECO 7FR, D, 2-6-2.; THMCL SMTCH SF BID, TC, D-F.