MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G50224

Device Problem Material Puncture/Hole (1504)

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

Event Date 01/19/2022

Event Type  malfunction  

Event Description

As reported, during an unspecified procedure a advance 18 lp low profile balloon catheter was found not to inflate due to a leak.The balloon catheter was advanced to the popliteal artery via a cook guiding sheath.The user began inflating with a balloon expansion pressure pump, but upon inflating they found that pressure could not be maintained and the contrast substance was leaking from the balloon.No angulation or vessel tortuosity was noted.The balloon was then removed with the sheath.Another new balloon catheter was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

A follow up report will be submitted should additional relevant information become available.

Event Description

Information was available and inadvertently omitted from the original report.The lesion was 70% occluded.The vessels were reportedly not calcified.The device was inflated to eight atmospheres when the leak was observed.The balloon was not inflated within a stent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.

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, unchanged, or unavailable.Summary of event: as reported, during an unspecified procedure a advance 18 lp low profile balloon catheter was found not to inflate due to a leak.The balloon catheter was advanced to the popliteal artery via a cook guiding sheath.The user began inflating with a balloon expansion pressure pump, but upon inflating 8 atmospheres they found that pressure could not be maintained and the contrast substance was leaking from the balloon.The balloon was then removed with the sheath.No angulation or vessel tortuosity was noted.The lesion was 70% occluded.The vessels were reportedly not calcified.The balloon was not inflated within a stent.Another new balloon catheter was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, drawings, instructions for use (ifu), quality control procedures, and specifications were conducted during the investigation.A visual inspection of the complaint device was also conducted.Physical examination and leak testing of the returned device confirmed that the balloon was leaking during inflation.The leak was coming from the balloon material, not the balloon bond.Cook completed a review of the device history record (dhr).The dhr found 1 relevant nonconformance, however, the non-conforming product was scrapped.Additionally, a lot history search found no other complaints have been reported for this lot number.Because there were no other related non-conformances, adequate inspection activities had been established, there was objective evidence that the dhr was fully executed, and no other lot related complaints had been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu) provided with the device state, "particular care should be taken in handling the balloons to prevent damage.They will inflate to the indicated size parameters when utilizing proper pressure recommendations.Adhere to balloon inflation parameters indicated in the compliance card insert." the ifu also warns, "do not exceed the rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures," and, "do not use a power injector for balloon inflation or injection of contrast medium through catheter lumen marked 'distal'.Rupture may occur." cook concluded that patient anatomy contributed to this incident.The user stated the lesion was 70% occluded when advancing the device which likely caused the failure of the balloon material.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.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 18 LP LOW PROFILE BALLOON CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13384697
• MDR Text Key: 284816348
• Report Number: 1820334-2022-00135
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002502243
• UDI-Public: (01)10827002502243(17)240423(10)13914716
• Combination Product (y/n): N
• PMA/PMN Number: K073378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G50224
• Device Catalogue Number: PTA4-18-135-3-10
• Device Lot Number: 13914716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2021
• 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: FLEXOR BALKIN GUIDING SHEATH
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 58 KG