MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number G52332

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 04/10/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Name and address -(b)(6).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

As reported, during a procedure to treat peripheral arterial occlusive disease, an advance 35 lp low profile balloon catheter's balloon leaked from a pinhole.Another manufacturer's 7-french sheath and 0.035-inch wire were used during the procedure.The balloon was inflated one time within a 60% occluded lesion in the knee, using another manufacturer's inflation device; however, the pressure decreased upon reaching six atmospheres.The anatomy was reportedly not tortuous or calcified.The balloon was not inflated within a stent.Blood was noted in the inflation device as the balloon pressure decreased.After the leak occurred, the balloon was allowed to return to ambient pressure; however, negative pressure was not maintained upon removal of the device, and a counter-clockwise rotation of the balloon was not conducted.The balloon was removed from the patient by itself, leaving the wire in place, and another balloon of the same type 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.According to the initial reporter, the patient did not experience any adverse effects due to this 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, unchanged, or unavailable.Summary of event: as reported, during a procedure to treat peripheral arterial occlusive disease, an advance 35 lp low profile balloon catheter's balloon leaked from a pinhole.Another manufacturer's 7-french sheath and 0.035-inch wire were used during the procedure.The balloon was inflated one time within a 60% occluded lesion in the knee, using another manufacturer's inflation device; however, the pressure decreased upon reaching six atmospheres.The anatomy was reportedly not tortuous or calcified.The balloon was not inflated within a stent.Blood was noted in the inflation device as the balloon pressure decreased.After the leak occurred, the balloon was allowed to return to ambient pressure; however, negative pressure was not maintained upon removal of the device, and a counter-clockwise rotation of the balloon was not conducted.The balloon was removed from the patient by itself, leaving the wire in place, and another balloon of the same type 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.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Corrected information: h6 (annex a).Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), specifications, and quality control procedures were conducted during the investigation.A visual inspection and functional test of the complaint device was also conducted.The complaint device was returned to cook for investigation.A pinhole leak was noted in the balloon during leak testing, near the proximal marker band.A review of the device history record found no related non-conformances on the lot.One similar complaint has been received from the field.Cook reviewed the device master record.100% inspections are in place for leaks in the balloon up to nominal operating pressure and for debris on the balloon surface.Based on a review of relevant manufacturing documentation, cook has concluded that sufficient inspections are in place to identify this failure mode prior to distribution.The product ifu warns "do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure 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 pressure." the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to manufacturing or design, contributed to this event.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 35 LP LOW PROFILE BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• 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: 16753872
• MDR Text Key: 313499579
• Report Number: 1820334-2023-00447
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002523323
• UDI-Public: (01)10827002523323(17)250512(10)CINC001497
• Combination Product (y/n): N
• PMA/PMN Number: K091527
• 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
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G52332
• Device Catalogue Number: PTA5-35-80-4-4.0
• Device Lot Number: CINC001497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2022
• 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: BD PRESSURE GAUGE.; TERUMO 0.035 WIRE.; TERUMO 7FR SHEATH.
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 78 KG