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

Model Number	G52372
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: lead tech.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a procedure involving placement of a stent within the common iliac vein, an advance 35 lp low profile balloon catheter ruptured longitudinally upon the first inflation within a cook 16-millimeter stent.The patient had a history of venous disease, and the anatomy was calcified (per intravenous ultrasound).An unspecified 8 french, 13-centimeter cook sheath was used during the procedure.The complaint device was inflated to eleven atmospheres, using an unknown inflation device, to pre-dilate the common iliac vein (within the stent) at the time of rupture.Blood was noted in the inflation device at the time of rupture.The balloon was removed through the sheath, and another manufacturer's 10-millimeter balloon was used to successfully finish the procedure and place an unspecified cook 10-millimeter stent.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.
Additional Manufacturer Narrative
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 or Problem Description
Upon return and initial evaluation of the device, the catheter itself was noted to be ruptured 11cm from the distal tip.
Event or Problem Description
No additional information has been received since the last report was submitted.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a procedure involving placement of a stent within the common iliac vein, an advance 35 lp low profile balloon catheter ruptured longitudinally upon the first inflation within a cook 16-millimeter stent.The patient had a history of venous disease, and the anatomy was calcified (per intravenous ultrasound).An unspecified 8 french, 13-centimeter cook sheath was used during the procedure.The complaint device was inflated to eleven atmospheres, using an unknown inflation device, to pre-dilate the common iliac vein (within the stent) at the time of rupture.Blood was noted in the inflation device at the time of rupture.The balloon was removed through the sheath, and another manufacturer's 10-millimeter balloon was used to successfully finish the procedure and place an unspecified cook 10-millimeter stent.Upon return and initial evaluation of the device, the catheter itself was noted to be ruptured 11cm from the distal tip.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.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 complainant returned one advance 35 lp low profile balloon catheter to cook for investigation.Physical examination of the returned device revealed that there was a hole in the catheter body, eleven centimeters from the distal tip.Further investigation was necessary to show the longitudinal rupture of the balloon as originally reported.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu instructs the user to inspect the product upon removal from the package.The label on the product package indicates that for the pta5-35-80-10-3.0, the nominal inflation pressure is 8 atm/bar and the rated burst pressure is 11 atm/bar.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is objective evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy contributed to this event, as vessel calcification and metal from the stent likely caused the reported balloon rupture.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
• Common Device Name: 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: 13710185
• Report Number: 1820334-2022-00366
• Device Sequence Number: 14811004
• Product Code: DQY
• UDI-Device Identifier: 10827002523729
• UDI-Public: (01)10827002523729(17)250111(10)14463046
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2025
• Device Model Number: G52372
• Device Catalogue Number: PTA5-35-80-10-3.0
• Device Lot Number: 14463046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 03/08/2022; 04/29/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 03/30/2022; 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BARD 10MM DORADO PTA BALLOON; COOK ZILVER VENA 16MM X 140MM STENT
• Patient Age: 51 YR
• Patient Sex: Male