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

Catalog Number PTAX4-14-170-2-12

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation = rt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported, during an unspecified procedure, the advance 14 lp low profile balloon catheter leaked.According to the initial reporter, when attempting to inflate the device, it would not inflate.The user noticed blood inside the balloon device and suspected a hole or leak.At that time, the balloon device was removed and another device of the same type 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 information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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.

Event Description

Additional information received 20apr2020.As reported, the device was used to treat a 100% occluded below-the-knee lesion.The patient's vessel was moderately calcified but was not angulated or tortuous.The device was utilized through a 6 french 45 cm ansel sheath.

Manufacturer Narrative

Initial report: it was reported, during an unspecified procedure, the advance 14 lp low profile balloon catheter leaked.According to the initial reporter, when attempting to inflate the device, it would not inflate.The user noticed blood inside the balloon device and suspected a hole or leak.At that time, the balloon device was removed and another device of the same type 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: reviews of the documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and a visual inspection as well as a functional test of the device were conducted during the investigation.Examination of the returned package confirmed that one used ptax4-14-170-2-12 was returned to cook for investigation.Attempted inflation of the returned device confirmed that the balloon was unable to be inflated.There was biomatter present on the device.There was no damage noted to the balloon or catheter shaft.The device was decontaminated for 5 days.Additional device analysis was performed on 15jul2020.The balloon was attempted to be inflated; however, the inflation attempt was unsuccessful.When pulling back on the syringe, some blood clots were pulled into the syringe.As blood clots were found during attempted inflation, it is suspected that there is biomatter that is creating an occlusion in the lumen.Device analysis was unable to confirm a leak in the balloon or balloon catheter shaft.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.However, upon review, no gaps were discovered in the manufacturing instructions, specifications, drawing, or quality control procedures for this device.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.An ifu is provided with this device, which states ¿if resistance is met while advancing the balloon dilatation catheter, determine the cause and proceed with caution¿inflate balloon to desired pressure.Adhere to recommended balloon inflation pressures¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ cook has concluded that a definitive conclusion could not be determined.The information provided upon review of complaint file, device master record, and design validation testing provide objective evidence to support that the device was manufactured to specification.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 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
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9956977
• MDR Text Key: 187523155
• Report Number: 1820334-2020-00805
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K170193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2022
• Device Catalogue Number: PTAX4-14-170-2-12
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6 FRENCH, 45CM ANSEL SHEATH