MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	G50317
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = unknown.Pma/510(k) number = k170193.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 lower extremity runoff procedure involving a patient with severely calcified vessels below-the-knee, an advance 14 lp low profile balloon catheter ruptured.The device was advanced through an unspecified 6 french ansel sheath and then inflated, using a cook inflation device, within "normal parameters" when the balloon ruptured.The balloon did not separate, and was removed over an unknown wire guide.Another of the same device was used to complete the procedure without complication.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
Initial report summary: as reported, during a lower extremity runoff procedure involving a patient with severely calcified vessels below-the-knee, an advance 14 lp low profile balloon catheter ruptured.The device was advanced through an unspecified 6 french ansel sheath and then inflated, using a cook inflation device, within "normal parameters" when the balloon ruptured.The balloon did not separate, and was removed over an unknown wire guide.Another of the same device was used to complete the procedure without complication.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.Reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and specifications the device as well as a visual inspection and functional test of an unused device were conducted during the investigation.The complaint device was not returned; however, during examination of the representative unit from the same lot, the balloon was inflated with water using a cook inflation device to the rated burst pressure, 16atm.Once inflated to 16atm, the balloon did not rupture and there was no leakage.There were no surface defects to balloon or damage noted to device.The balloon bonds were smooth.A document-based investigation evaluation was performed.The evidence indicates the product was made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.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 that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.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, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.¿ & ¿do not use a power injector for balloon inflation.Rupture may occur.¿ the ifu goes on to note ¿if resistance is encountered while advancing the balloon dilatation catheter, determine the cause and proceed with caution.¿ as well as ¿inflate balloon to desired pressure.Adhere to recommended balloon inflation pressures.(see compliance card insert.)¿ and finally, ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ based on the information provided and no product returned, investigation has concluded that the patient¿s anatomy is likely the cause for this event.Reportedly, the patient had severe calcification below the knee.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 14 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: 9553470
• Report Number: 1820334-2020-00057
• Device Sequence Number: 11537241
• Product Code: LIT
• UDI-Device Identifier: 10827002503172
• UDI-Public: (01)10827002503172(17)220822(10)9965645
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/15/2020

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: 08/22/2022
• Device Model Number: G50317
• Device Catalogue Number: PTAX4-14-170-2-12
• Device Lot Number: 9965645
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR