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Catalog Number PTA5-35-80-8-4.0
Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Patient Problems Cardiac Arrest (1762); Death (1802); Deformity/ Disfigurement (2360)
Event Date 02/07/2018
Event Type  Death  
Manufacturer Narrative
Concomitant medical products: amplatz wire, 4 fr merit sheath with radio-opaque tip. (b)(4). 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 that during an iliac angioplasty (as a precursor for femoral popliteal bypass) at noon on (b)(6) 2018, the advance 35 lp low profile balloon catheter was easily inserted, incompletely inflated once to below nominal pressure, ruptured and seared off inside of the patient at a pressure less than 8 atm. The physician stated he was watching the screen when the balloon burst and he is not able to clarify the actual pressure the balloon burst at. The balloon catheter markers also came off within the patient's anatomy. A 50:50 ratio of contrast to saline was utilized during the procedure. Another manufacturer's 4 fr sheath with a radio-opaque tip and an amplatz wire guide (manufacturer unspecified) were utilized during the procedure. The patient's external iliac artery (eia) was noted to be significantly calcified and tight. Access to the lesion (focal stenosis - vessel approximately 8 millimeters) at the common iliac artery (cai) / external iliac artery (eia) junction was gained via an ipsilateral approach; there was 5 to 10 centimeters (cm) between the end of the 4 fr sheath with radio-opaque tip. Upon withdrawal of the ruptured advance 35 lp low profile balloon catheter, resistance was encountered. Negative pressure was maintained on the ruptured balloon using an inflation device. Gentle traction was maintained on the balloon shaft, and the 4 fr sheath with radio-opaque tip was held in place to facilitate re-sheathing. The balloon catheter snapped ten (10) centimeters from the distal end with "much less than expected amount of force" applied. The proximal catheter portion and disconnected marker were able to be retrieved endovascularly; however, the distal catheter portion remained in situ and stuck on arterial calcification. As a result of this event, the patient was noted to be left with a larger scar. The patient required emergency transfer to the operating room for removal of the distal catheter portion two hours after the iliac angioplasty. A large retroperitoneal incision was made, and the wire and retained device were able to be surgically retrieved extensive retroperitoneal approach. The patient went on to have an endarterectomy of the index lesion (left iliac calcification). After a three (3) hour operation, the patient was sent to recovery and woken up. He complained of intractable pain in his leg. The leg was ischemic and despite having already restored inline flow to the groin, the leg was no longer viable and the patient returned to the operating room and an amputation was performed that evening. Minimal time was spent in recovery. Following the event, the patient was placed in the intense treatment unit (itu) stay. The patient's stay on itu was short and uneventful, the patient underwent step-down care, and was returned to the ward. It was further reported that the patient suffered an event, on day five which led to cardiac arrest and death. Additional information regarding whether the patient had any other pre-existing conditions prior to the procedure, and the official cause of cardiac arrest and death, has been requested but is not available at this time.
Manufacturer Narrative
Additional information was received from the customer. The first of the reported procedures was completed at 8:00 pm. The patient was then observed in recovery. The patient returned to the theatre for a left above the knee amputation, which was completed at 11:00 pm. Additionally, it was confirmed that a death certificate was issued by the consultant vascular surgeon. A post-mortem examination was not performed, but the cause of death was recorded as: 1a - ischaemic heart disease. 2 - peripheral vascular disease (operated on - above knee amputation). Further information regarding the event that led to the reported cardiac arrest was also provided. The patient was extubated at 5:00 am on (b)(6) 2018 in the intensive therapies unit (itu). The patient was then discharged from the itu on (b)(6) 2018. Increasing shortness of breath was reported on (b)(6) 2018. The arrest call was made at 9:15 pm, with 24 minutes of cardiopulmonary resuscitation (cpr) performed before cpr efforts were discontinued. The patient's expiration was verified at 11:15 pm on (b)(6) 2018. Further extensive notes were reportedly generated regarding the incident, but were not provided by the customer. Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation. The visual inspection of the returned device confirmed that the device had separated into two segments. 1. 5 cm of accordion damage were noted on the balloon tubing approximately 5mm from the distal end of the distal segment. The balloon tubing was green, indicating that it had been stretched, and was 10. 2 cm in length. The proximal separated segment was measured to be 21 mm in length, and the distal separated segment was measured to be 20 mm in length. The total measured length of 41 mm is within specifications. It was also confirmed that the balloon burst radially. The proximal segment of the entire catheter is 76. 7 cm long, and the distal segment is 10. 8 cm long. The total length of the catheter is 87. 5 cm, which is above the upper specification for the device. Additionally, a document based investigation evaluation was performed. The device history record was reviewed for lot number 8325575, and 3 non-conformances were noted in the manufacturing department. A review of the non-conformance data revealed that the non-conformances listed on the device history record were for leaks at the proximal band. However, the non-conformances noted were scrapped before the work order was processed as normal. It should be noted there were no other reported complaints for this lot number. Based on the information provided, the examination of the returned product, and the results of our investigation, several root causes were identified. The root cause for the device failure has been determined to be damage to the balloon that resulted from a heavily calcified plaque. It was determined that the root cause for the difficult retrieval was the use of the 5 french balloon catheter with an incompatible 4 french sheath. As a result, the ruptured balloon was lodged in the sheath. Additionally, the balloon catheter was stretched prior to separation, which had been observed fluoroscopically; therefore the separation of the balloon catheter was due to user technique. Measures are being conducted to address this failure mode. We will continue to monitor for similar complaints. Per the quality engineering risk assessment, no further action is required.
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Manufacturer (Section D)
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
MDR Report Key7322430
MDR Text Key101829463
Report Number1820334-2018-00405
Device Sequence Number1
Product Code DQY
UDI-Device Identifier10827002523590
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPTA5-35-80-8-4.0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/07/2018 Patient Sequence Number: 1