MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (135 CM GUIDE; PERCUTANEOUS, IMPLANTED LONT TERM INTRAVASCULAR CATHETER

Catalog Number 3275135

Device Problem Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 evaluate.Results are expected soon.A lot history review (lhr) of reap0364 showed no other similar product complaint(s) from this lot number.

Event Description

Bas engineers found that a guidewire returned for evaluation was kinked.No patient injury reported.

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 kinked guidewire is confirmed, and the cause is found to be manufacturing related.The product returned included two powerpicc devices and one 135-cm guidewire in its hoop, reportedly from 5 fr d/l rad power picc w/ 135 gw kits.The flexible tip was kinked at one spot and severely bent close to this point, with one other bend nearer the tip, and therefore the measurement was approximate.Microscopic observation confirmed that the kink in the tip featured wide gaps between coil wires.Catheter #1 ended distal to the 44-cm depth mark, and catheter #2 ended distal to the 43-cm depth mark.The distal surface of catheter #1 was found microscopically to be very smooth and striated.The distal surface of catheter #2 was very uneven, but also glossy and striated.Whitish-yellow material was found on this end, with what appeared to be slight blood residue.Functional testing showed that each catheter was patent to infusion (both lumens).The stylet returned was placed back into its hoop and thoroughly wetted.That the lubriciousness of the stylet had increased was then noted.The stylet could then be moved distally through each lumen of each device, and then removed.Tracking sample #1 along the guidewire, starting at the proximal end of the guidewire, as would be done in an over-the-guidewire procedure, showed that neither lumen would allow the guidewire through.The stopping place of the wire was in the vicinity of the bifurcation.When the bifurcation area was sectioned, the guidewire could be passed through the lumens of all but the central piece containing the letters ¿pow¿ from ¿powerpicc¿ in the printing.Tracking sample #2 along the guidewire in the same manner showed that the purple lumen would not allow the guidewire through.The stopping place of the wire was in the vicinity of the bifurcation.When the bifurcation area was sectioned, the guidewire could be passed through the pieces.After sectioning the bifurcation area of sample #1, it was found that clear material was partially obstructing the paths of both lumens.After sectioning the bifurcation area of sample #2, a fold of clear material was found inside the purple lumen partially obstructing the path.Manufacturing review confirmed a molding issue within the catheter bifurcations.The material noted within the lumens and consequent difficulty of threading over the guidewire is considered the likely cause of the tip kinking, as it would cause an unexpected obstacle to threading and possible excessive manipulation of the guidewire.The kink will therefore be addressed in this file.The presence of extra material within several lumens in these catheters shows that this complaint is manufacturing related.The 135 cm guidewire ifu: ¿insert and advance the catheter - insert the catheter slowly over the wire, through the introducer sheath, and into the vessel.Advance the catheter tubing until approximately 5 cm remains outside the sheath.¿.

• Brand Name: POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (135 CM GUIDE
• Type of Device: PERCUTANEOUS, IMPLANTED LONT TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: maren treft ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 6028881
• MDR Text Key: 57643044
• Report Number: 3006260740-2016-00549
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741027925
• UDI-Public: (01)00801741027925(17)200728(10)REAP0364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Catalogue Number: 3275135
• Device Lot Number: REAP0364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1