MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 6 FR DL POWERPICC WITH 135 CM GUIDEWIRE; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Catalog Number	3276135
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2017
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 manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that during picc insertion, the interventional radiologist could not get the guidewire into the svc as it kept tracking up.When adjusting the wire, the guidewire allegedly unravelled.
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, 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 an unraveled guidewire could not be verified since the wire was not returned for investigation.One 6 fr d/l powerpicc was the only item returned for investigation.The picc appeared to be unused.The catheter length had not been modified.The catheter was patent to infusion and no leaks were observed.Since the damaged component was not returned for investigation, the complaint could not be verified and was inconclusive.The product ifu provides cautions to prevent guidewire damage.
Event or Problem Description
It was reported that during picc insertion, the interventional radiologist could not get the guidewire into the svc as it kept tracking up.When adjusting the wire, the guidewire allegedly unravelled.

• Brand Name: 6 FR DL POWERPICC WITH 135 CM GUIDEWIRE
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6525704
• Report Number: 3006260740-2017-00518
• Device Sequence Number: 248398
• Product Code: LJS
• UDI-Device Identifier: 00801741028007
• UDI-Public: (01)00801741028007
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K050931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2017

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 Catalogue Number: 3276135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1