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

Model Number	D128210
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
It was reported that upon arrival of the pentaray nav high-density mapping eco catheter shipment, it was noticed that the packaging was damaged with puncture holes through to the sterile inner pouch.The pentaray nav high-density mapping eco catheter never used on patient.No patient consequences were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.On january 22, 2020, the biosense webster, inc.Product analysis lab received the device for evaluation, and it was noted that upon initial visual inspection, the outer box has shipping damage.The product was returned in original outer box and the pouch was unopened (never used).The puncture points reported by the customer were not visible with visual inspection.The first visual inspection is assessed as not reportable; however, the file remains mdr reportable for the customer's initially reported issue.Further analysis is pending.
Additional Manufacturer Narrative
Investigation summary: it was reported that upon arrival of the pentaray nav high-density mapping eco catheter shipment, it was noticed that the packaging was damaged with puncture holes through to the sterile inner pouch.The pentaray nav high-density mapping eco catheter never used on patient.No patient consequences were reported.The device was received with the original box and the outer box was observed damaged.However, the internal packaging was observed without damage, the pouch was observed unopened.Further inspection was performed on the pouch and it was observed in normal condition and no damages were observed.A manufacturing record evaluation was performed for the finished device 30294364l number, and no internal actions was found during the review.The customer experience was not confirmed since the pouch was observed in good condition.Manufacturer's reference # (b)(4).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9655987
• Report Number: 2029046-2020-00165
• Device Sequence Number: 1810376
• Product Code: MTD
• UDI-Device Identifier: 10846835012248
• UDI-Public: 10846835012248
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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: 09/23/2022
• Device Model Number: D128210
• Device Catalogue Number: D128210
• Device Lot Number: 30294364L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1