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Model Number PED-375-16
Device Problem Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2016
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned for evaluation; however, return is anticipated. Without return of the device, no definitive conclusions can be drawn regarding the clinical observation. Should the device be returned or additional information become available, a supplemental report will be submitted. Information received from the same report as mfr: 2029214-2016-00412.
Event Description
Medtronic received information that during treatment of an aneurysm a fracture was noted at the distal marker of two delivery wires. It was reported that during delivery the (ped-375-16) device became stuck within the microcatheter. In the second attempt the initial part was pushed out, but further deployment was not possible and the device was unable to be resheathed. The device was removed from the patient and a fracture was noted on the delivery wire. A second device (ped2-375-18) was used and reported to have the same issue. No patient injury was reported.
Manufacturer Narrative
The pipeline flex pushwire and the microcatheter were returned for evaluation. It appeared that the pipeline flex pushwire was detached at the hypotube proximal to the wire weld. The detached distal segment of the pushwire and pipeline braid were found outside of the catheter. The remaining segment of the pushwire was found inside of the microcatheter. The catheter body was found to be accordioned. For further examination, the remaining segment of the pushwire was then pushed out of the catheter lumen with difficulty. The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact. The pipeline braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified. The pipeline braid was found fully opened with moderately fraying at both ends. The pushwire was observed to be bent. No other anomalies were observed. The surfaces of the detached pushwire were sent out for scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) analyses. Based on the reported event details, the analysis findings and the sem/eds analyses, the clinical observation was confirmed. We are unable to definitively determine the cause of the reported experience. The elemental analysis conducted through scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) showed presence of soldering material (tin); thereby indicating that the soldering was conducted. In addition, a review of the manufacturing process did not uncover any deficiencies with regard to the soldering process. However, the damages observed on the pushwire proximal wire, pipeline braid, hypotube and catheter body suggest excessive force such as pushing and pulling. It is possible that the ¿moderate vessel tortuosity¿ may have contributed to the ¿gradual resistance¿; subsequently causing the devices to become damaged and detached. However, the cause for the resistance could not be determined. In this event, the user context may have contributed to the reported issues as the physician continued to advance the pipeline flex delivery system despite of the resistance. Per our instructions for use, the user should "discontinue delivery of the device if high force or excessive friction is encountered. Identify the cause of the resistance and remove device and microcatheter simultaneously. Advancement of the ped against resistance may result in device damage or patient injury. All products are 100% inspected for damage and irregularities during manufacture.
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Manufacturer (Section D)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
MDR Report Key5737162
MDR Text Key47793532
Report Number2029214-2016-00413
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/16/2018
Device Model NumberPED-375-16
Device Lot NumberA122258
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial