MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G50333

Device Problems Material Puncture/Hole (1504); Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

Reporter occupation: head tech.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, during a below the knee angioplasty, the balloon ruptured from a advance 14 lp low profile balloon catheter.A 6fr cook ansel 45cm sheath was also utilized during the procedure.The lesion was located in the posterior tibia with 90% occluded.The inflation device used was from another manufacturer.The balloon had been inflated at least two times and the duration of the inflations is unknown.The inflation pressure was unknown.There was blood noted in the inflation device.The contrast used for inflation was unknown.They were able to remove the device by removing the balloon over the wire.There was no angulation or vessel tortuosity noted, but there was vessel calcification due to a significant amount of calcified plague.The procedure was already completed prior to the device rupture.No unintended section of the device remained inside of the patient.No additional procedures were required due to this occurrence.No adverse effects to the patient were reported due to the occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Correction- b1, h1: a leak test of the returned device showed a pinhole leak 6mm proximal to the proximal bond site in the catheter shaft.No rupture of the balloon was observed.There was no evidence from the device analysis that the returned device was manufactured out of specification.There is no evidence to suggest that the observed device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury took place, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11297281
• MDR Text Key: 263154352
• Report Number: 1820334-2021-00282
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002503332
• UDI-Public: (01)10827002503332(17)231030(10)13524965
• Combination Product (y/n): N
• PMA/PMN Number: K170193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2023
• Device Model Number: G50333
• Device Catalogue Number: PTAX4-14-170-3-20
• Device Lot Number: 13524965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6 FR COOK ANSEL 45 CM; BOSTON SCIENTIFIC INFLATION DEVICE