MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER, 4 F SL, 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recw0473 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during insertion the 3cg wire bent in a few places and during removal, the wire completely severed.It was stated the same picc catheter was placed with a different wire.It was stated there was no patient harm.
Event or Problem Description
It was reported that during insertion the 3cg wire bent in a few places and during removal, the wire completely severed.It was stated the same picc catheter was placed with a different wire.It was stated there was no patient harm.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a break in the 3cg stylet was confirmed.One 3cg stylet was returned for investigation.The stylet had been removed from the t-lock extension set.The core wire was coiled.The picc and t-lock extension set were not returned for investigation.There was a break in the polyimide tubing.The break in the core wire coincided with the break in the polyimide tubing.The distal segment of the polyimide tubing was 3.6cm in length.A kink was observed in the polyimide tubing 3.1 cm from the distal tip of the distal stylet segment.The proximal segment of polyimide tubing was 3.8cm.The polyimide tubing was kinked between the eight adjacent magnets proximal to the break site.The wall thickness of the polyimide tubing was within specification.The kinking of the polyimide tubing suggests that the catheter may have encountered resistance during insertion; however, the exact cause of the reported event could not be determined from the returned sample.It was reported that the 3cg stylet bent during insertion.The retraction of the stylet through the t-lock extension set may have been a contributing factor in the complete break of the polyimide tubing.The ifu states, ¿slowly remove the t-lock and stylet, as a unit.Do not remove stylet through t-lock.¿ a lot history review (lhr) of recw0473 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC SOLO CATHETER, 4 F SL, 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8441847
• Report Number: 3006260740-2019-00620
• Device Sequence Number: 2170594
• Product Code: LJS
• UDI-Device Identifier: 00801741136535
• UDI-Public: (01)00801741136535
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CK000687
• Device Lot Number: RECW0473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1