MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F FULL; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Catalog Number	1174108
Health Effect - Clinical Code	Burning Sensation (2146)
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.A lot history review (lhr) of (b)(4) showed no other similar product complaint(s) from this lot number.The following were reviewed as part of this investigation: patient severity, trend 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 leaking catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 4fr s/l powerpicc catheter.Usage residues were evident throughout the sample.The catheter terminated at the 47cm depth marking.Microscopic inspection of the distal end of the sample revealed striations typical of a sharp instrument cut.The extension tube markings were completely worn.Depth marking wear was observed between the 7cm and 11cm depth markings.A longitudinally aligned split was observed between the 11cm and 12cm depth marking.The distal end of the split occurred within a region of kinked and compressed shape memory.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, a spraying leak was observed emanating from the site of the aforementioned split.Tactile inspection of the sample revealed tensile weakness in the vicinity of the split.The catheter kinked preferentially at the site of the kinking impression during manual manipulation of the sample.Microscopic inspection of the split revealed sharply defined edges.The edges exhibited a dully granular texture.The coarseness of the granularity varied along the length of the split.The characteristics of the split were consistent with burst damage caused by over-pressurization of the sample.Over-pressurization may have occurred as a result of flushing against an occlusion.The position of the kink shape memory relative to the split suggested that a catheter kink may have caused the occlusion.The proximity of the split to the region of worn depth markings suggested that the split occurred close to the surface and catheter fixation technique may have contributed to the occluding kink.The product ifu states ¿catheters that present resistance to flushing and aspiration may be partially or completely occluded.Do not flush against resistance.¿.
Event or Problem Description
Per sales representative, facility reported that a patient came in (b)(6) 2015 to have picc line removed.Patient stated that he was unable to flush and home care nurse told him to push hard.Patient stated he heard a pop and when infusing medication, it burned in his arm.Upon removal, the catheter was flushed and a hole was noted.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F FULL
• Common Device Name: PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5352565
• Report Number: 3006260740-2015-00633
• Device Sequence Number: 235725
• Product Code: LJS
• UDI-Device Identifier: 00801741034442
• UDI-Public: (01)00801741034442(17)161228(10)REZH0632
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Report Date (Section B): 12/14/2015

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 Expiration Date: 12/28/2016
• Device Catalogue Number: 1174108
• Device Lot Number: REZH0632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2015
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1