MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET BASI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	1173118
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device has not yet been returned for evaluation.
Event or Problem Description
It was reported that the there was a break in the catheter present at 8cm mark, break extended 0.5cm, tip of catheter intact.There was no patient injury reported.
Additional Manufacturer Narrative
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 catheter leak was confirmed and the cause appears to be use related.The product returned for evaluation was 3fr powerpicc sv catheter.The damage observed in the returned sample was characteristic of over-pressurization (burst) damage.This can occur through the use of syringes smaller than 10ml, by flushing against an occlusion, or due to excessive force applied during infusion procedures.The returned product sample was evaluated and a split was observed between the 6cm-7cm depth marking.This catheter damage was typical of a burst, and the characteristics observed which supported this type of failure included: longitudinally-aligned split.Tensile weakness at the fracture site (due to material ballooning prior to burst).Granular fracture surface texture (typical of tearing failure modes).The catheter tubing was measured to be within specification.Exceeding the maximum power injection flow rate of 300 psi and flushing against an occlusion can cause this type of failure.Additionally, the product ifu provides the following warning, ¿failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.¿ and, ¿failure to warm contrast media to body temperature prior to power injection of contrast media may cause failure of the catheter.¿ an examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) of rebs1492 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the there was a break in the catheter present at 8cm mark, break extended 0.5cm, tip of catheter intact.There was no patient injury reported.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET BASI
• 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: 7383943
• Report Number: 3006260740-2018-00559
• Device Sequence Number: 11049475
• Product Code: LJS
• UDI-Device Identifier: 00801741086892
• UDI-Public: (01)00801741086892
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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: 1173118
• Device Catalogue Number: 1173118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1