MAUDE Adverse Event Report: COOK INC ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	G26724
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common name & product code: dqy catheter, percutaneous; lit catheter, angioplasty, peripheral, transluminal.(b)(6).Occupation: unknown/ sister.(b)(4).A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an above and below-the-knee angioplasty, an advance micro 14 ultra low-profile pta balloon catheter ruptured and separated during inflation within the superficial femoral artery.Reportedly, the balloon broke off before the user could blow up the balloon.The separated portion of the device was retrieved via a cut-down procedure.Additional details regarding the event have been requested, but are unavailable at this time.
Event or Problem Description
Additional information was received 10apr2020.An unknown 6 french sheath was used during the procedure.An unknown device was used to inflate the balloon, using a 50/50 solution of optiray contrast and saline, to 6-8 atmospheres.It is unknown how many times the device was inflated; however, the balloon was removed from the body between inflations.The balloon was reportedly removed with the sheath as a unit.Lesions were located in the distal superficial and popliteal arteries, as well as the tibioperoneal trunk.The vessels were mild to moderately calcified, but were not tortuous.Blood was not noted in the inflation device, and the balloon was not inflated within a stent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Initial report: as reported, during an above and below-the-knee angioplasty, an advance micro 14 ultra low-profile pta balloon catheter ruptured and separated during inflation to 6-8 atmospheres within the superficial femoral artery.It is unknown how many times the device was inflated; however, the balloon was removed from the body between inflations.The balloon was reportedly removed with the sheath as a unit.Lesions were located in the distal superficial and popliteal arteries, as well as the tibioperoneal trunk.The vessels were mild to moderately calcified, but were not tortuous.Reportedly, the balloon broke off before the user could blow up the balloon.The separated portion of the device was retrieved via a cut-down procedure.Investigation ¿ evaluation.Reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, specifications, and a visual inspection of the device were conducted during the investigation.The visual inspection of the returned device confirmed that one used pta3-14-150-3-12 was returned to cook for investigation.Biomatter was present on the returned device.The catheter was separated into two segments.The balloon was not present with the returned catheter segments.Both returned segments of the catheter shaft had numerous kinks and bends.Additionally, a document-based investigation evaluation was performed.A review of the device history record showed one relevant, potentially failure-related nonconforming event; all affected devices were scrapped.It should be noted there were no other reported lot-related complaints.There were no identified gaps in the device drawing, specifications, manufacturing instructions, or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information available provides evidence to support that the device was manufactured to specification.An ifu is provided with this device, which 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.¿ cook has concluded that a definitive cause could not be determined.It is possible that patient¿s moderately calcified anatomy could have contributed to this incident.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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 MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9947977
• Report Number: 1820334-2020-00792
• Device Sequence Number: 3258234
• Product Code: LIT
• UDI-Device Identifier: 10827002267241
• UDI-Public: (01)10827002267241(17)220422(10)9684714
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K122940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2020

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: 04/22/2022
• Device Model Number: G26724
• Device Catalogue Number: PTA3-14-150-3-12
• Device Lot Number: 9684714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 04/10/2020; 06/03/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 04/15/2020; 06/05/2020
• 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 0.014 INCH HYDRO ST WIRE GUIDE G52939
• Outcome Attributed to Adverse Event: Required Intervention