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

Model Number	G30963
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = unknown.Pma/510(k) number = k130293.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 interventional procedure of the superficial femoral and popliteal arteries, an advance 18 lp low profile balloon catheter ruptured and separated.The female patient of unknown age reportedly had a history of hypertension, peripheral artery disease, and diabetes.The anatomy was reported to be tortuous with a calcified bifurcation and popliteal artery.A 6 french raabe sheath was used during the procedure as well as an unknown inflation device and another manufacturer's 0.014 inch wire guide.The complaint balloon was inflated two times, with 'roughly' 30% visipaque contrast, to an unknown pressure within the highly calcified popliteal artery.The balloon was not removed and reinserted between inflations.The balloon ruptured circumferentially at an unknown pressure and separated.Blood was observed in the inflation device at the time of rupture.The balloon was not inflated inside of a stent.All portions of the device were removed and no additional procedures were required.A new balloon was used to complete the procedure as intended.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one circumferentially ruptured pta4-18-150-6-17, a 6fr flexor sheath and an unidentified wire guide were returned for investigation.The wire guide was inside the balloon catheter, and the balloon catheter was still inserted inside the sheath.Upon removal of the wire, it was noted to be curled.The balloon catheter was wrinkled and stuck inside the sheath.The flexor sheath check-flo was disassembled to find the separated piece of balloon inside the check-flo body.The balloon was separated and torn circumferentially; however, both markers were still present.The proximal marker band was on the catheter and the distal band was inside the separated piece of balloon.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawing, specifications, and quality control procedures were conducted, and no gaps were discovered.An ifu is also 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.¿ based on the information provided and the examination of the returned product, cook has concluded patient anatomy contributed to this incident.It was reported that the patient¿s anatomy was tortuous, and highly calcified.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measures are being taken to address this failure mode.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.

• Brand Name: ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9234788
• Report Number: 1820334-2019-02684
• Device Sequence Number: 19430224
• Product Code: LIT
• UDI-Device Identifier: 10827002309637
• UDI-Public: (01)10827002309637(17)220725(10)9903817
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

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: 07/25/2022
• Device Model Number: G30963
• Device Catalogue Number: PTA4-18-150-6-17
• Device Lot Number: 9903817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 12/16/2019
• 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: VIPERWIRE 0.014 INCH.