MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT PACIFIC; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Catalog Number PCF06004013P

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During an attempt at treating a lesion reported to exhibit plaque in the proximal right sfa using in.Pact pacific paclitaxel eluting balloon catheter, it was reported that the balloon was slow to deflate at the lesion site.Physician experienced deflation difficulties.There was no injury to patient or clinical sequelae reported for this event.¿please note that this device (in.Pact pacific) is not marketed in the united states; however, it is similar to the united states marketed device (in.Pact admiral).This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.¿.

Manufacturer Narrative

Device evaluation: visual and a tactile inspection were carried out on the returned device: dry blood was found on the device.It was returned with the 6f introducer sheath used during the procedure.Two kinks were detected on the shaft - at 5 cm and at 26.5cm from the strain relief tube.The introducer sheath was flushed and it was slid on the device, in order to be able to inspect all shaft length.In that portion of shaft, previously covered by the introducer sheath, about 6 cm of flattened shaft was detected.The device was flushed and a 0.018¿ guide wire was successfully advanced through the device from the tip to the luer.Negative pressure was applied with a manometric syringe on the balloon: purging test was successfully performed, without bubbles detected.A pre-decontamination analysis of balloon inflation/deflation at nominal pressure was performed and a very slow deflation for both of the tests was noted: the time registered was 1 min and 50s (110s).During the analysis post-decontamination, the deflation time was tested again.The device was prepared as per ifu and then the balloon was inflated to the nominal pressure.Then, deflation time was registered, confirming the results obtained during pre-decontamination tests.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: IN.PACT PACIFIC
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6075182
• MDR Text Key: 59064724
• Report Number: 9612164-2016-01148
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Catalogue Number: PCF06004013P
• Device Lot Number: 0007713791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/03/2016
• Supplement Dates Manufacturer Received: Not provided; 11/17/2016
• Supplement Dates FDA Received: 12/06/2016; 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2015
• 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 Age: 84 YR
• Patient Weight: 75