MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-18 2.5/80/130 PERIPHERAL DILATATION CATHETER

Model Number 357502

Device Problem Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2017

Event Type  Injury  

Event Description

Ous mdr - the passeo-18 balloon was inserted into the patient with the balloon protector still applied. The balloon could not be inflated. The balloon protector was snared out and fully retrieved. The patient is a (b)(6) year old male.

Manufacturer Narrative

The device was discarded at the hospital. Therefore no technical investigation on the subject could be performed. Review of the production documentation verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspections. The provided angiographic material was reviewed but does not provide any additional information on the complaint event. The need to remove the protective sleeve prior to use, which is quite different in material and stiffness compared to the balloon itself, is a standard procedure for balloon catheters and mentioned in the related instruction for use. Based on the conducted investigations no material or manufacturing related root cause could be determined.

• Brand Name: PASSEO-18 2.5/80/130
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; buelach CH-81 80; SZ CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 6463792
• MDR Text Key: 71884412
• Report Number: 1028232-2017-01199
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K072765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 357502
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05165988
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial