MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC HF CATHETER WIT H BASIC KIT AND RADSTIC MICROINTRODUCER; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	3385355Q
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 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 5fr t/l powerpicc catheter.Usage residues were evident throughout the sample.The catheter terminated between the 44cm and 45cm depth markings.Microscopic inspection of the distal end of the catheter revealed striations typical of a sharp instrument cut.A permanent sharp kinking impression was observed between the 5cm and 6cm depth markings.A longitudinally aligned split was observed at the 2cm depth marking.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 in the vicinity of the split during manual manipulation.Material discoloration was observed at the kink site.Microscopic inspection of the split revealed sharply defined granular edges.A small hole was observed near the middle of the split.The outside surface of the catheter was abraded and deformed in the vicinity of the hole.Inspection of the inside surface of the catheter opposite the split was unremarkable.The kinking and tensile weakness were typical of damage caused by excessive manipulation of the catheter.The material abrasion and deformation were indicative of contact between the catheter and some abrasive surface.The split was the result of that contact.The damage may have been the result of catheter securement techniques.Care should be taken when securing, accessing and maintaining catheters to avoid causing damage.A lot history review (lhr) of reap0980 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On (b)(6) 2016- per sales representative, facility reported that after a picc was placed they were unable to draw blood and had difficulty flushing.It was said that they checked for a mechanical obstruction, flushed the picc and then noticed saline leaking from insertion site.The picc was further retracted, flushed twice and reportedly a puncture was noted.The picc was removed.

• Brand Name: POWERPICC HF CATHETER WIT H BASIC KIT AND RADSTIC MICROINTRODUCER
• 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: 5693057
• Report Number: 3006260740-2016-00241
• Device Sequence Number: 16143847
• Product Code: LJS
• UDI-Device Identifier: 00801741028205
• UDI-Public: (01)00801741028205(17)180928(10)REAP0980
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/11/2016

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: 09/28/2018
• Device Catalogue Number: 3385355Q
• Device Lot Number: REAP0980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2016
• Initial Report FDA Received Date: 06/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1