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

Model Number	G30958
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported, during a leg angiogram of the superficial femoral artery, an advance 18 lp low profile balloon catheter ruptured longitudinally during use.Following the rupture of a previous balloon (reported under patient identifier (b)(6), the device was introduced using a 6fr cook sheath and inflated once for approximately three seconds using an inflation device and a 70/30 saline to contrast ratio.The balloon was inflated to approximately ten atmospheres at the time of rupture.The balloon was utilized after a laser atherectomy device was used to open up the vessel, leaving an approximately 30% occluded lesion.According to the initial reporter, the atherectomy device caused a piece of jagged/sharp calcium, to which the performing physician attributes the balloon rupture.Following the rupture, the device was removed, and a third balloon from another manufacturer was used to successfully complete the procedure.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
Summary of event: it was reported, during a leg angiogram of the superficial femoral artery, an advance 18 lp low profile balloon catheter ruptured longitudinally during use.Following the rupture of a previous balloon (reported under patient identifier (b)(6)), the device was introduced using a 6fr cook sheath and inflated once for approximately three seconds using an inflation device and a 70/30 saline to contrast ratio.The balloon was inflated to approximately ten atmospheres at the time of rupture.The balloon was utilized after a laser atherectomy device was used to open up the vessel, leaving an approximately 30% occluded lesion.According to the initial reporter, the atherectomy device caused a piece of jagged/sharp calcium, to which the performing physician attributes the balloon rupture.Following the rupture, the device was removed, and a third balloon from another manufacturer was used to successfully complete the procedure.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: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, specifications, and quality control procedures was conducted during the investigation.The complaint device was not returned; therefore, examination of the device was not possible.A document-based investigation evaluation was performed.Possibly-related non-conformances were noted on the complaint lot, but the devices were identified and scrapped prior to distribution.No other complaints have been reported on this lot.The information provided upon review of complaint file, device history record, complaint history, device master record, and design validation testing provide objective evidence to support that the device was manufactured to specification.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed product labeling.The label on the product package as well as the compliance card insert indicates that for the pta4-18-150-5-20, the nominal inflation pressure is 8atm and the rated burst pressure is 12atm.The ifu states: ¿the balloon is manufactured from an extra-thinwall, high-strength, minimally compliant material.Particular care should be taken in handling the balloon to prevent damage.It will inflate to the indicated size parameters when utilizing proper pressure recommendations.Adhere to balloon inflation pressure parameters indicated in the compliance card insert.Refer to label for further information.Use of a pressure gauge is recommended to monitor inflation pressures.¿.¿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.¿ a review of the manufacturer¿s instructions and quality control procedures was conducted, and no gaps were discovered.Based on the information provided and the results of the investigation, cook has concluded that that the patient¿s anatomy contributed to this incident.As reported, the physician stated he had previously performed a laser atherectomy to open the vessel.In doing so, there was a piece of jagged / sharp calcium.The calcified anatomy is what the physician believes popped the balloon.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 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: 9712713
• Report Number: 1820334-2020-00356
• Device Sequence Number: 16795006
• Product Code: LIT
• UDI-Device Identifier: 10827002309583
• UDI-Public: (01)10827002309583(17)220531(10)9777490
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: G30958
• Device Catalogue Number: PTA4-18-150-5-20
• Device Lot Number: 9777490
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1