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

Model Number N/A

Device Problems Balloon rupture (1049); Material Rupture (1546)

Patient Problems Foreign body, removal of (2365); Surgical procedure, additional (2564); No Code Available (3191)

Event Date 05/06/2015

Event Type  Injury  

Event Description

Information was provided that during a procedure, using another manufacturer's inflation device, the 10mm balloon was inflated once to below burst pressure.The ball burst (ruptured), then snapped and unraveled in the artery of the patient.As the balloon "fanned" out, it could not be removed through the sheath.The patient was taken to the theatre (surgery) for removal of the device.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Event is still under investigation at this time.

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, documentation, instructions for use (ifu), quality control, trends, and specifications was conducted during the investigation.The product was not returned for investigation.Should the device become available for investigation, the complaint will be reopened at that time.Per dfmea, balloon burst, compliance, and fatigue verification testing have been performed.The rated burst pressure (rbp) is documented in the compliance card and label.There is no evidence to suggest the device was not manufactured per specifications.Each device is shipped with ifu which states the appropriate uses, contraindications, warnings and precautions, and proper usage procedures including proper inflation and deflation procedures.The ifu states: 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.Do not use a power injector for balloon inflation or injection of contrast medium as rupture may occur.The ifu also states, if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.The rated burst pressure for this balloon is 11 atm.The user stated that the balloon was inflated once below burst pressure when it burst, thus over-inflation is not a likely cause for the rupture.The user stated "heavily calcified" as a pre-existing condition.It is possible that calcification could have contributed to the rupture and subsequent separation.Calcified areas can have unexpected sharp protrusions; which may increase the chance of balloon damage, tear, and/or rupture.The user did not report whether the burst was linear or circumferential.The user stated that the "balloon fanned out and would not come through the sheath." if the user attempted to withdrawal the ruptured balloon through the sheath, balloon rewrap would be very difficult and the balloon and/or catheter may tear as it experiences resistance during the attempted withdrawal.If the balloon ruptured circumferentially and attempted withdrawal through a sheath occurred, it is possible that the balloon may fold back on itself (inside/out like an umbrella) which would increase the chances of separation.The user stated, "balloon fanned out in patient after bursting would not come through the sheath, so removed sheath and tried to just remove the balloon and whole shaft broke in patient," so ultimately the user attempted to withdrawal the balloon separate from the sheath, but it appears as though the user may have tried to remove it through the sheath first which is against the instructions in the ifu.It is possible that the user not following proper removal instructions per the ifu may have contributed to the separation, but the root cause of the balloon rupture cannot be determined.We have notified the appropriate internal personnel and will continue to monitor for similar complaints.

Event Description

Information was provided that during a procedure, using another manufacturer's inflation device, the 10 mm balloon was inflated once to below burst pressure.The balloon burst (ruptured), then snapped and unraveled in the artery of the patient.As the balloon "fanned" out, it could not be removed through the sheath.The patient was taken to the theatre (surgery) for removal of the device.The patient did not experience any adverse effects due to this occurrence.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4827927
• MDR Text Key: 5910622
• Report Number: 1820334-2015-00337
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2018
• Device Model Number: N/A
• Device Catalogue Number: PTA5-35-80-10-4.0
• Device Lot Number: 5635174
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/06/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR