MAUDE Adverse Event Report: AV-TEMECULA-CT MINI TREK CORONARY DILATATION CATHETER

Catalog Number 1012270-12

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problems Death (1802); Non specific EKG/ECG Changes (1817); Ischemia (1942)

Event Date 04/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a de novo lesion located in the diagonal branch with heavy calcification and no tortuosity.The 2.0 x 12 mm mini trek rx was advanced to the lesion and crossed successfully.The balloon was inflated to 8 atmospheres during the first inflation and again to 10 atmospheres for the second inflation when a rupture occurred.It was stated that the balloon was not soaked in saline prior to use.It was reported that st elevation and slow blood flow in the vessel was observed when the balloon ruptured.A new device was used to successfully complete the procedure.There were no adverse patient effects or clinically significant delay in the procedure reported.However, it was reported that the patient expired the next day when awaiting for transfer to surgery to treat a severe aortic stenosis.It was believed that the death was unrelated to the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.The reported balloon rupture was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents from this lot.It should be noted that the mini trek rx, instruction for use, states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.The investigation determined the reported balloon rupture and patient effects/additional treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

The following additional information was received: prior to the initial procedure, the patient presented with dyspnea on exertion and syncope.The patient was given medication to treat the reported st elevation and slow blood flow.A 2.25 x 20 mm non-abbott stent was successfully implanted in the target lesion, which resolved the slow flow.The following day, while awaiting treatment of pre-existing aortic stenosis, an attempt was made to implant a permanent pacemaker at which time the patient became bradycardic and hypotensive.It was stated by the physician that the patient died from bradycardic arrest unrelated to the balloon rupture or percutaneous transluminal coronary procedure.Angiography prior to the patient death found no thrombus clots.No additional information was provided.

• Brand Name: MINI TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6574054
• MDR Text Key: 75401768
• Report Number: 2024168-2017-04229
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 1012270-12
• Device Lot Number: 61126G5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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