MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JINRO PIGTAIL; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number M0064202080

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a nephrostomy catheter set was unpacked on (b)(6) 2019.According to the complainant, during unpacking, a hair was found inside the product box.Reportedly, this was found prior to use with a patient or procedure.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

(lot number): per investigation lot number 23427949 was reported; however, it is unable to be populated in gcms.Therefore, the manufacture and expiration dates are unknown.Problem code 2944 captures the reportable event of foreign matter.Investigation result: visual examination found that a long hair was inside the product between the original pouch and the outer bag.It was also noted that the device was totally closed/sealed and packaged inside its original pouch, with no defects or issues.It is most likely that the failures found are related to the inappropriate transport or storage of the device; therefore the most probable root cause is cause traced to transport/storage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a nephrostomy catheter set was unpacked on july 05, 2019.According to the complainant, during upacking, a hair was found inside the product box.Reportedly, this was found prior to use with a patient or procedure.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Block h6: problem code a180104 captures the reportable event of foreign matter.Block h10: investigation result visual examination found that a long hair was inside the product between the original pouch and the outer bag.It was also noted that the device was totally closed/sealed and packaged inside its original pouch, with no defects or issues.It is most likely that the failures found are related to the inappropriate transport or storage of the device; therefore the most probable root cause is cause traced to transport/storage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.Block h11: correction: block d1 (brand name), d2a (common device name), d4 (model number, catalog number, expiration date and unique identifier (udi)#), g1 (mfr site facility name, mfr site address 1, mfr site address 2, mfr site city and mfr site country), g2 (report source), g4 (premarket / 510(k) #), h4 (device manufacture date), h6 (impact codes and device codes) and block h10 (additional mfr narrative) have been corrected.

Event Description

It was reported to boston scientific corporation that a nephrostomy catheter set was unpacked on (b)(6), 2019.According to the complainant, during upacking, a hair was found inside the product box.Reportedly, this was found prior to use with a patient or procedure.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: JINRO PIGTAIL
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8840749
• MDR Text Key: 153117969
• Report Number: 3005099803-2019-03808
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K944290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2023

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: 03/07/2022
• Device Model Number: M0064202080
• Device Catalogue Number: 420-208
• Device Lot Number: 0023427949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 10/08/2019; 07/06/2023
• Supplement Dates FDA Received: 10/23/2019; 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1