MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PPICC, IR, 135 CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number 3174335J

Device Problems Knotted (1340); Migration or Expulsion of Device (1395); Physical Resistance (2578)

Patient Problem No Information (3190)

Event Date 04/18/2018

Event Type  Injury  

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) of reby1731 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that after puncturing the needle and confirming the backflow of blood, the operator inserted the guidewire into the superior vena cava.After inserting the sheath, when the operator inserted the catheter, he felt resistance.Therefore he removed the catheter.He tried to re-insert the guidewire through the sheath, but he felt resistance.Then, he confirmed that the distal end part of the guidewire tied up to a knot and he could not remove the guidewire.He made an incision at the puncturing site and removed the guidewire successfully.The physician inferred that "while he was trying to remove the guidewire which had migrated out of the vessel, the guidewire got to be tied up.".

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 that the guidewire was tied in a knot was confirmed and it appeared that the guidewire was damaged during use.One 0.018¿ x 135cm guidewire was received in its hoop.The blue tip straightener was not returned with the hoop.What appeared to be blood residue was observed on the hoop.A knot was observed in the coiled segment of the guidewire 1.6cm from the distal weld tip.The coiled section of the guidewire was curled proximal to the knot.A microscopic examination revealed blood and use residue within the knotted section of the guidewire.A tactual investigation revealed that the weld tip was intact.Due to the evidence of use on the guidewire, it appeared that the wire inadvertently folded over itself and was twisted into a knot during the procedure.It was reported that the guidewire was inserted into the superior vena cava.Had the knot existed prior to use, the wire would not have fit through the needle.No manufacturing related defects were noted on the complaint sample.A review of the device history record (dhr) showed no deviations/issues associated with this problem in regards to product materials, manufacturing, or qc inspection processes.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of reby1731 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that after puncturing the needle and confirming the backflow of blood, the operator inserted the guidewire into the superior vena cava.After inserting the sheath, when the operator inserted the catheter, he felt resistance.Therefore he removed the catheter.He tried to re-insert the guidewire through the sheath, but he felt resistance.Then, he confirmed that the distal end part of the guidewire tied up to a knot and he could not remove the guidewire.He made an incision at the puncturing site and removed the guidewire successfully.The physician inferred that "while he was trying to remove the guidewire which had migrated out of the vessel, the guidewire got to be tied up.".

• Brand Name: PPICC, IR, 135 CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7500062
• MDR Text Key: 107779780
• Report Number: 3006260740-2018-00940
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741111716
• UDI-Public: (01)00801741111716
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3174335J
• Device Lot Number: REBY1731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 97 YR