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

Model Number	G30952
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products= kcfw-6.0-18/38-45-rb-anl0-hc; bard presto inflation device; terumo advantage 0.018 glidewire.(b)(6).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 a percutaneous transluminal angioplasty of the distal superficial femoral/above-the-knee popliteal artery via contralateral access, an advance 18 lp low profile balloon catheter ruptured and separated.The balloon was inflated one time to ten atmospheres, using 50% saline and "visipac 270" contrast and another manufacturer's inflation device, when it ruptured circumferentially.The vessel was very severely calcified; however, angulation and tortuosity were not reported.The lesion being treated at the time of the event was highly stenosed and approximately 20 centimeters long.Blood was observed in the inflation device after the balloon ruptured.The balloon was not inflated within a stent.Upon attempted removal of the device over another manufacturer's 0.018 inch wire guide, it became stuck at the valve of the 6 french cook sheath and subsequently separated.A counter-clockwise rotation of the balloon was not conducted during attempted removal of the device.The separated portion of the device, along with the sheath and wire guide, were removed together.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
Event summary: as reported, during a percutaneous transluminal angioplasty of the distal superficial femoral/above-the-knee popliteal artery via contralateral access, an advance 18 lp low profile balloon catheter ruptured and separated.The balloon was inflated one time to ten atmospheres, using 50% saline and "visipac 270" contrast and another manufacturer's inflation device, when it ruptured circumferentially.The vessel was very severely calcified; however, angulation and tortuosity were not reported.The lesion being treated at the time of the event was highly stenosed and approximately 20 centimeters long.Blood was observed in the inflation device after the balloon ruptured.The balloon was not inflated within a stent.Upon attempted removal of the device over another manufacturer's 0.018 inch wire guide, it became stuck at the valve of the 6 french cook sheath and subsequently separated.A counter-clockwise rotation of the balloon was not conducted during attempted removal of the device.The separated portion of the device, along with the sheath and wire guide, were removed together.Investigation - evaluation.Reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications and a visual inspection of the device were conducted during the investigation.One used pta4-18-150-4-20 was returned for investigation.Physical examination of the returned device confirmed that the balloon ruptured circumferentially and separated.Biomatter was present throughout the device.Approximately 6cm of balloon remained attached to the catheter.The inner catheter lumen in the balloon was not present.No marker bands were present on the device.There was no damage noted to catheter shaft or fitting.A document-based investigation evaluation was also conducted.A review of the device history record showed no nonconforming events which could have contributed to this failure mode.A review of complaint history showed no additional complaints received related to this lot.Reviews of the manufacturing instructions, drawing, specifications, and quality control procedures were also conducted, and no gaps were discovered.The available information provides objective evidence to support that the device was manufactured to specification.The product is packaged with instructions for use 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.¿ the ifu further advises, ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.Based on the information available, investigation has concluded that the patient¿s severe vessel calcification 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 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 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: 9769324
• Report Number: 1820334-2020-00496
• Device Sequence Number: 19529686
• Product Code: LIT
• UDI-Device Identifier: 10827002309521
• UDI-Public: (01)10827002309521(17)201204(10)8415876
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Report Date (Section B): 05/06/2020

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: 12/04/2020
• Device Model Number: G30952
• Device Catalogue Number: PTA4-18-150-4-20
• Device Lot Number: 8415876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1