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

Model Number	G52359
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Codes	No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter occupation = lead tech.(b)(4).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 an aortoiliofemoral (aif) procedure to open the superficial femoral artery, an advance 35 lp low profile balloon catheter ruptured and separated.The iliac arteries were reportedly extremely calcified but were not tortuous or angulated.A 6 french sheath was unable to be advanced via the left groin into the right iliac, so the complaint device was used to open the stenosed external iliac artery.The balloon was inflated using an inflation device and visipaque contrast; however, the balloon ruptured and separated upon the first inflation.The device was removed, and another manufacturer's snare was used to retrieve the separated balloon fragments.Blood was noted in the inflation device after the balloon ruptured.The balloon was not inflated within a stent.The access site was closed, and the patient was transported to a hospital for further treatment.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Summary of event: as reported, during an aortoiliofemoral (aif) procedure to open the superficial femoral artery, an advance 35 lp low profile balloon catheter ruptured and separated.The iliac arteries were reportedly extremely calcified but were not tortuous or angulated.A 6 french sheath was unable to be advanced via the left groin into the right iliac, so the complaint device was used to open the stenosed external iliac artery.The balloon was inflated using an inflation device and visipaque contrast; however, the balloon ruptured and separated upon the first inflation.The device was removed, and another manufacturer¿s snare was used to retrieve the separated balloon fragments.Blood was noted in the inflation device after the balloon ruptured.The balloon was not inflated within a stent.The access site was closed, and the patient was transported to a hospital for further treatment.A section of the device did not remain inside the patient¿s body.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), manufacturing instructions, quality control, and specifications were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complainant returned one pta5-35-80-8-4.0 balloon catheter to cook for investigation.Physical examination of the returned device showed the device was returned in two pieces.Biomatter was present on the returned device.Approximately 1.5cm of balloon material remained on the catheter.The balloon was ruptured circumferentially.Only one marker band was present.The separated piece measured approximately 9cm.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 information provided upon review of complaint file, device history record, complaint history, device master record, and design verification testing provide objective evidence to support that the device was manufactured to specification.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.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, which resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.¿ the ifu also instructs: ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ 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 incident.As reported, the patient¿s iliac arteries were reportedly extremely calcified, and a 6 fr sheath was unable to advance into the stenosed right iliac.Because the sheath would not advance, the complaint device was used to open the stenosed iliac artery.It is suspected that hardened calcium punctured and tore the balloon upon inflation of the device.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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
• MDR Report Key: 11086886
• Report Number: 1820334-2020-02365
• Device Sequence Number: 19635146
• Product Code: DQY
• UDI-Device Identifier: 10827002523590
• UDI-Public: (01)10827002523590(17)231015(10)13491785
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/15/2023
• Device Model Number: G52359
• Device Catalogue Number: PTA5-35-80-8-4.0
• Device Lot Number: 13491785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK 6X45 ANSEL SHEATH, CID-20-3; COOK 6X45 ANSEL SHEATH, CID-20-3
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 200