MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	G52358
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cordis (b)(6) powerflex ; cordis's brite tip sheath 6fr; terumo's radifocus 0.035inch wire.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 endovascular treatment procedure, an advance 35 lp low profile balloon catheter ruptured.A retrograde approach was gained from the left femoral artery to treat a 90% occluded, calcified lesion within the left external iliac artery.Another manufacturer's wire guide was passed through the lesion and an unknown 3-millimeter balloon was used to pre-dilate the lesion.The complaint device was then advanced to the lesion.The user attempted to inflate the balloon using an unknown inflation device; however, it did not inflate.The balloon was removed from the body by itself and a ten-centimeter, longitudinal tear was noted on the tip of the balloon, from the distal side.Another manufacturer's device was then used to complete the procedure.Reportedly, a pre-operative inspection was not performed.Blood was not noted in the inflation device.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
Initial report: as reported, during an endovascular treatment procedure, an advance 35 lp low profile balloon catheter ruptured.A retrograde approach was gained from the left femoral artery to treat a 90% occluded, calcified lesion within the left external iliac artery.Another manufacturer's wire guide was passed through the lesion and an unknown 3-millimeter balloon was used to pre-dilate the lesion.The complaint device was then advanced to the lesion.The user attempted to inflate the balloon using an unknown inflation device; however, it did not inflate.The balloon was removed from the body by itself and a ten-centimeter, longitudinal tear was noted on the tip of the balloon, from the distal side.Another manufacturer's device was then used to complete the procedure.Reportedly, a pre-operative inspection was not performed.Blood was not noted in the inflation device.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 of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.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.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.No gaps were discovered in the manufacturer¿s instructions, 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 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 goes on to note ¿if resistance is met while advancing the balloon dilatation catheter, determine the cause and proceed with caution.¿ a capa was previously completed to address the increasing trend of balloon rupture for pta4 and pta5 devices.The capa identified root causes related to inadequate manufacturing controls.The complaint device was manufactured prior to the conclusion of capa implementation actions.Cook has concluded that the patient¿s anatomy most likely contributed to this incident.The user stated that the balloon might have torn when it was advancing in the lesion because the lesion was calcified.Based on the user¿s statement, it is believed that the inadequate manufacturing related controls identified as the root causes in the capa are most likely not related to this incident.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.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.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10138595
• Report Number: 1820334-2020-01103
• Device Sequence Number: 11342590
• Product Code: DQY
• UDI-Device Identifier: 10827002523583
• UDI-Public: (01)10827002523583(17)210517(10)8890304
• Combination Product (Y/N): N
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 05/17/2021
• Device Model Number: G52358
• Device Catalogue Number: PTA5-35-80-8-2.0
• Device Lot Number: 8890304
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1